Program-2023

Program is subject to change. 

PRE-RECORDED LECTURES

Novel Trial Designs
Leveraging Large Datasets in Clinical Trial Design 

Workshop Pretest

Completed online between Saturday, July 22 and Sunday, July 23

SUNDAY, JULY 23

Registration
1:30 pm-5:30 pm

Faculty Meeting
4:30 pm-5:15 pm

Welcome/Overview
5:30 pm-5:45 pm

Opening Keynote Lecture
5:45 pm-6:30 pm

Dinner
6:30 pm-7:15 pm

Protocol Development Group Session
7:30 pm-9:00 pm

MONDAY, JULY 24

Breakfast
7:00 am-8:00 am

Lecture Session 1
8:00 am-10:00 am

  • Clinical Trial Design: Asking Important Questions that Impact Our Patients
  • Answering Important Questions: From Hypothesis to Analysis
  • Phase I Trial Questions
  • Phase I Trial Designs

Questions / Panel Discussion

Break
10:00 am-10:20 am

Lecture Session 2
10:20 am-12:00 pm

  • Phase II Trial Questions/Objectives
  • Phase II Trial Designs
  • Drug Combination Trials
  • Multimodality Trials

Questions / Panel Discussion

Lunch
12:00 pm-1:30 pm

Protocol Development Group 2
1:30 pm-4:00 pm

Independent Study Time
4:00 pm-7:00 pm

Office Hours 1 (Biostatisticians and Patient Advocates; prescheduled appointments)
4:30 pm-6:30 pm

ASSIGNMENT DUE: PROTOCOL TEMPLATE
7:00 pm

Dinner
7:00 pm-9:00 pm

TUESDAY, JULY 25

Breakfast
7:00 am-8:00 am

Special Lecture
8:00 am-8:30 am

Lecture Session 3
8:30 am-10:00 am

  • Feasibility and Reproducibility in Biomarker Studies
  • Incorporation of Biological Correlative Studies into Early Clinical Trials
  • Statistical Aspects of Correlative Studies

Questions / Panel Discussion

Break
10:00 am-10:30 am

Lecture Session 4
10:30 am-11:45 am

  • Imaging in the Era of Targeted Therapy and Immunotherapy
  • Special Considerations in the Design of Immunotherapy Studies
  • Inflammatory and Immunologic Biomarkers

Questions / Panel Discussion

Lunch
11:45 am-12:45 pm

Protocol Development Group Session 3
12:45 pm-3:45 pm

Break
3:45 pm-4:00 pm

Office Hours 2: Protocol Related Questions
4:00 pm-6:00 pm

Independent Study Time
3:45 pm-7:00 pm
Pizza and salads available from 5:00 pm-7:00 pm

ASSIGNMENT DUE: STATISTICAL DESIGN
7:00 pm

WEDNESDAY, JULY 26

Breakfast
7:00 am-8:00 am

Small Group Discussion Sessions 1-3
8:00 am-9:00 am

  • Elements of Artificial Intelligence
  • Symptom Management, Patient Reported Outcomes, and Quality of Life
  • Phase III Trials

Break
9:00 am-9:15 am

Small Group Discussion Sessions 4-6
9:15 am-10:15 am

  • Navigating the National Clinical Trials Network
  • Incorporation of Digital Health and PROs
  • Laboratory Correlates

Break / Group Photo
10:15 am-10:45 am

Small Group Discussion Sessions 7-9
10:45 am-11:45 am

  • Defining, Identifying, and Knowing Your Trial’s Clinical Endpoints
  • First in Human Trials: Understanding the Regulatory Process
  • Large-Scale Genomic Analysis: Bench to Bedside

Lunch
11:45 am-12:30 pm

Protocol Development Group Session 4
12:30 pm-2:30 pm

Independent Study Time/Dinner on Own
2:30 pm-7:00 pm

ASSIGNMENT DUE: PROTOCOL DRAFTS
7:00 pm

THURSDAY, JULY 27

Breakfast
7:00 am-8:00 am

Lecture Session 5
8:00 am-9:40 am

  • You’re In Charge: Investigator Responsibilities
  • How to Pay For Your Trial
  • Everything You Need to Know About Clinical Trial Ethics and Informed Consent: A Case Study
  • Community Engagement

Questions / Panel Discussion

Break
9:40 am-9:55 am

Lecture Session 6
9:55 am-11:35 am

  • Data Collection: It’s All In the Data
  • Inclusivity in Clinical Trials

Questions / Panel Discussion

Break
11:35 am-11:45 am

Keynote Lecture
11:45 am-12:35 pm

Lunch
12:35 pm-1:30 pm

Protocol Development Group Session 5
1:30 pm-3:00 pm

Independent Study Time/Dinner on Own
3:00 pm-7:00 pm

Office Hours 3
3:30 pm-5:00 pm

Optional Networking Session: Women in Hematology/Oncology
5:15 pm-6:15 pm

ASSIGNMENT DUE: INFORMED CONSENT DOCUMENTS
7:00 pm

FRIDAY, JULY 28

Breakfast
7:00 am-8:30 am

Faculty Meeting (Faculty Only)
7:30 am-8:30 am

Optional Career Sessions
(Exact topics to be determined based on accepted applicant interests, topics shown below are examples from past Workshops)
8:30 am-9:30 am

  • Collaborating with Industry
  • Careers in Radiation Oncology
  • Career Transition Tips

Break
9:30 am-9:45 am

Lecture Session 7
9:45 am-11:10 am

  • Successful Grantsmanship
  • Reporting and Presenting Results

Questions / Panel Discussion

Break
11:10 am-11:20 pm

Protocol Development Group Session 6
11:20 am-1:00 pm

Lunch
1:00 pm-1:30 pm

Administration of Post-test
1:30 pm-2:30 pm

Independent Study Time
2:30 pm-7:00 pm

ASSIGNMENT DUE: FINAL PROTOCOLS, INFORMED CONSENT FORMS, and ALL WORKSHOP EVALUATIONS
7:00 pm

Closing Reception / Banquet / Dance
7:00 pm-11:00 pm

SATURDAY, JULY 29

Continental Breakfast
5:00 am-8:00 am

Departure (on own)